A 16-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Reslizumab (0.3 or 3.0 mg/kg) as Treatment for Patients (12-75 Years of Age) With Eosinophilic Asthma.
Phase of Trial: Phase III
Latest Information Update: 18 Aug 2016
At a glance
- Drugs Reslizumab (Primary)
- Indications Asthma; Eosinophilia
- Focus Registrational; Therapeutic Use
- Acronyms BREATH
- Sponsors Cephalon; Teva Branded Pharmaceutical Products R&D
- 18 Aug 2016 According to a Teva Pharmaceuticals media release, based on the data from this and other four trials (700194103, 700194191, 700212125 & 700194454) the European Commission has granted marketing authorization for reslizumab for the treatment of asthma.
- 24 Jun 2016 According to a Teva Pharmaceuticals media release, based on the data from this and other four trials (700194103, 700194191, 700212125 & 700194454) the EMA's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorization for reslizumab for the treatment of severe eosinophilic asthma. The final decision by the European Commission is expected in the second half of 2016.
- 28 Apr 2016 Time frame of the primary end point changed from only 16 weeks to Day 0 (baseline, pre-dose), Weeks 4, 8, 12 and 16.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History